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: Pharmacokinetic (PK) data supported the safety of these changes, confirming that the drug's effectiveness in maintaining protective IgG levels remains consistent even with faster administration. Summary of Benefits vs. Risks Clinical Observation Primary Indication Treatment of Primary Immunodeficiency (PI). Key Advantage

: Recent studies (e.g., Study GTI1503) demonstrated that Xembify is well-tolerated at higher infusion rates of $\geq$35 mL/hour/site , compared to the previously approved maximum of 25 mL/hour/site . 125683

: This increase allows for significantly shorter infusion times, which is a major factor in treatment adherence and quality of life for patients requiring long-term immune globulin replacement therapy. : Pharmacokinetic (PK) data supported the safety of